Protocol summary

Study aim
Studying the effect of dexmedetomidine in reducing the incidence of AKI in diabetic patients receiving oral therapy during CABG surgery, On-Pump beating Study of changes in urea, creatinine, cardiac output, and GFR before, during, and after CABG surgery in the study groups. postoperative discharge rate, and duration of ventilatory support in the intensive care unit.
Design
Clinical trial with two groups of Dex and placebo by double blindness on 90 patients (Placebo 45 and Dex 45)
Settings and conduct
In Qaim Hospital in Mashhad, 60 diabetic patients are receiving Dex or placebo infusion from the time of admission until they are transferred to the ICU.
Participants/Inclusion and exclusion criteria
35 <age<70 years, EF > 35%, diabetes treated with medication, candidate for elective CABG On-Pump beating with two or more grafts, provided that one of the grafts is the LIMA, HR> 65 on admission, GFR>50, ASA class II, hematocrit > 30% No concomitant heart valve surgery, underlying diseases Exclusion criteria: Reoperations and non-coronary, CABG Off-Pump, patient sensitivity to dexmedetomidine family of drugs, return to operating room from ICU, history of previous cardiac surgery, history of fever, trauma, bilateral carotid artery stenosis > 50%, difficult or prolonged intubation > 20 seconds, body mass index > 30, HR < 65/min, LM > 50%, history of bundle branch block, history of treatment with clonidine or methyldopa, presence of IABP
Intervention groups
Dexmedetomidine infusion is started with an infusion pump in the dex group (dex diluted in saline at a concentration of 0.5 μg/kg/h) and in the placebo group, normal saline is started with an infusion pump at the same rate and continues until the end of the surgery.
Main outcome variables
Incidence of AKI in the first 48 hours after surgery in the ICU Creatinine and urea changes daily (on admission and 24 hours later) in the open heart ICU

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251013067605N1
Registration date: 2025-10-19, 1404/07/27
Registration timing: prospective

Last update: 2025-10-19, 1404/07/27
Update count: 0
Registration date
2025-10-19, 1404/07/27
Registrant information
Name
Islamic Republic of Iran Soolaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4724 7769
Email address
www.mahsasoolaki75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-24, 1404/09/03
Expected recruitment end date
2026-03-16, 1404/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of intraoperative dexmedetomidine infusion on acute renal failure in diabetic patients undergoing CABG surgery
Public title
Effect of Dexmedetomidine on Acute Renal Injury Patients undergoing CABG
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
EF>35% Diabetic patient treated with medication Candidate for Elective CABG On-Pump beating with two or more grafts, provided that one of the grafts is the left internal mammary artery (LIMA) HR > 65 on arrival GFR>50 ASA Class II classification Hct>30% The patient shouldn't have emergency surgery, concurrent valve surgery, or underlying renal, pulmonary, gastrointestinal, hepatic, or thyroid disease. Age between 35 to 70
Exclusion criteria:
Reoperations and non-coronary procedures CABG Off-Pump Return to the operating room from the ICU History of previous heart surgery History of fever, trauma Bilateral carotid artery stenosis > 50% Intubation difficult or takes longer than 20 seconds BMI > 30 kg/m² HR>65 LM>50% History of bundle branch block History of treatment with clonidine or methyldopa IABP
Age
From 35 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Despite of giving informed consent, participants are unaware of whether they are receiving the drug or placebo. Similarly, the outcome assessor only sees and notes the outcomes and he is unaware of whether the patient received the drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Imam Reza Hospital Educational, Research and Treatment Center - Mashhad University of Medical Scienc
Street address
Ahmadabad Boulevard, Qaim Hospital (AJ)
City
MASHHAD
Province
Razavi Khorasan
Postal code
9176697839
Approval date
2025-10-11, 1404/07/19
Ethics committee reference number
IR.MUMS.IRH.REC.1404.171

Health conditions studied

1

Description of health condition studied
Patients with diabetes treated with pills
ICD-10 code
N17.9
ICD-10 code description
Acute kidney failure, unspecified

Primary outcomes

1

Description
Incidence of postoperative AKI in diabetic patients undergoing CABG who received dexmedetomidine.
Timepoint
The incidence of AKI is determined by measuring urea and creatinine before, during, and after surgery.
Method of measurement
Blood test and urine output

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dexmedetomidine (Medonex) diluted in saline at a concentration of 0.5 micrograms/kg/hour) In the placebo group, normal saline solution was administered via an infusion pump at the same rate and continued until the end of the surgery.
Category
Prevention

2

Description
Control group: In the placebo group,0.9% normal saline solution was administered by infusion pump at a rate of 0.5 micrograms/kg/hour, starting at the beginning of surgery and continuing until the end of surgery.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Mehdi Kahrom
Street address
Qaem Hospital, Ahmadabad Bvld
City
MASHHAD
Province
Razavi Khorasan
Postal code
9176697839
Phone
+98 915 099 2515
Email
mahsasoolaki75@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Vakil Abad Blvd, Mashhad University of Medical Sciences
City
MASHHAD
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3882 7677
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
DR.Mahdi Kahrom
Position
Cardiovascular Surgery Specialist
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Ahmad Abad Boulevard. Qaim Hospital (Aj)
City
MASHHAD
Province
Razavi Khorasan
Postal code
9176697839
Phone
+98 51 3840 0000
Email
KahromMH@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mehdi Kahrom
Position
Cardiovascular Surgery Specialist
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Ahmad Abad Boulevard. Qaim Hospital
City
MASHHAD
Province
Razavi Khorasan
Postal code
9176697839
Phone
+98 51 3840 0000
Email
KahromMH@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mehdi Kahrom
Position
Cardiovascular Surgery Specialist
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Ahmad Abad Boulevard. Qaim Hospital (Aj)
City
MASHHAD
Province
Razavi Khorasan
Postal code
9176697839
Phone
+98 51 3840 0000
Email
KahromMH@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
I have not y decided et, but if the data is requested by email to the corresponding author, the data will be made available to other researchers. The report of the end of the study project will be registered in the Mashhad University of Medical Sciences' researcher system; the resulting article will be published in reputable journals.
When the data will become available and for how long
If data is requested by email to the corresponding author, the data will be made available to other researchers within one week.
To whom data/document is available
Responsible author
Under which criteria data/document could be used
If the applicant has an approved proposal from one of the medical universities, the data will be made available to the researcher.
From where data/document is obtainable
Responsible author
What processes are involved for a request to access data/document
If data is requested by email to the corresponding author, the data will be made available to other researchers.
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